MD&M East

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Medical device manufacturers that want to avoid a long deficiency letter will want to pay close attention to FDA’s final cybersecurity guidance, updated in June 2025 (and again in February 2026).
JD Supra

Updates to AdvaMed Code Coincide With Increased FDA, DOJ Focus on Device Cybersecurity

The Advanced Medical Technology Association (AdvaMed) updated its Code of Ethics effective November 1, 2025, primarily to add a new section on “data-driven technologies,” including the security of ...
JD Supra

From Vulnerability to Violation: FDA Cybersecurity Requirements for Medical Devices and FCA Enforcement

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 ...
MD&M East

FDA’s AI Device Regulations: Key Updates & Compliance Strategies for Medtech Success

FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing ...